South Korea - Clarification of review criteria for registration of pharmaceutical patent list published

Ministry of Food and Drug Safety clarified review criteria for registration of pharmaceutical patent list published

- The requirements for registration of the current patent list are limited to basic information such as the presence or absence of patent applications and direct relevance to approval matters, thus, specific review criteria for the patent for subject to be registered, proofs of direct relevance will be established by delegating it to the sub-regulations.

2) Introduction of provision for restricting the deletion of registration of patent list related marketing exclusivity (Article 50-3, paragraph 5)

- Where the patent challenge for a registered patent is succeeded and the exclusive marketing approval is granted, the system shall be supplemented and operated by enabling the registration to be maintained for the period of marketing exclusivity even if the registered patentee requests to delete the registered patent.

3) Clarification of the scope of the same product that the marketing is prevented according to marketing exclusivity (Article 50-9, paragraph 1)

- The scope of the marketing prevention of the same pharmaceutical product according to the exclusive marketing approval shall be defined by clarifying the pharmaceutical which product approval is granted after the application date of exclusive marketing approval.

4) Exemption from payment of the registration fee where the deletion of the registration of the patent list related to exclusive marketing approval is restricted (Article 82-2, paragraph 1) 

- Where the deletion of the registration is restricted for the period of marketing exclusivity, the patent registrant's obligation shall be exempt even if the patent registrant requests to delete the registration pursuant to Article 50-3, paragraph 5.

Products covered:Pharmaceuticals

HS Code:30

Proposed date of adoption:To be determined

Proposed date of entry into force:To be determined

Final date for comments:60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.